Home NDC 10122-212 Bronchitol
Product NDC 10122-212
11-digit product format 101220212
Labeler code 10122
Product ID 10122-212_379b5638-1dd3-4383-927f-2c1e04da8e33
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name mannitol
Dosage form CAPSULE
Route RESPIRATORY (INHALATION)
Labeler Chiesi USA, Inc.
Application NDA202049
Marketing category NDA
Marketing start 2021-02-01
Marketing end 0000-00-00
Substance MANNITOL
Active strength 40 mg/1
Pharmacologic classes Increased Diuresis [PE],Osmotic Activity [MoA],Osmotic Diuretic [EPC]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 5 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N202049-001 BRONCHITOL MANNITOL 40MG POWDER / INHALATION RLD, RS 2020-10-30
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N202049-001 ODE-327 2027-10-30
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 N202049-001 BRONCHITOL 40MG POWDER / INHALATION RLD, RS 2020-10-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N202049-001 BRONCHITOL 40MG POWDER / INHALATION RLD, RS 2020-10-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202049-001 BRONCHITOL 40MG POWDER / INHALATION RLD, RS 2020-10-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N202049-001 BRONCHITOL 40MG POWDER / INHALATION RLD, RS 2020-10-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202049-001 BRONCHITOL 40MG POWDER / INHALATION RLD, RS 2020-10-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202049-001 BRONCHITOL 40MG POWDER / INHALATION RLD, RS 2020-10-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N202049-001 BRONCHITOL 40MG POWDER / INHALATION RLD, RS 2020-10-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N202049-001 BRONCHITOL 40MG POWDER / INHALATION RLD, RS 2020-10-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N202049-001 BRONCHITOL 40MG POWDER / INHALATION RLD, RS 2020-10-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N202049-001 BRONCHITOL 40MG POWDER / INHALATION RLD, RS 2020-10-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N202049-001 BRONCHITOL 40MG POWDER / INHALATION RLD, RS 2020-10-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N202049-001 BRONCHITOL 40MG POWDER / INHALATION RLD, RS 2020-10-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N202049-001 BRONCHITOL 40MG POWDER / INHALATION RLD, RS 2020-10-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N202049-001 BRONCHITOL 40MG POWDER / INHALATION RLD, RS 2020-10-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N202049-001 BRONCHITOL 40MG POWDER / INHALATION RLD, RS 2020-10-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N202049-001 BRONCHITOL 40MG POWDER / INHALATION RLD, RS 2020-10-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N202049-001 BRONCHITOL 40MG POWDER / INHALATION RLD, RS 2020-10-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N202049-001 BRONCHITOL 40MG POWDER / INHALATION RLD, RS 2020-10-30 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N202049-001 BRONCHITOL 40MG POWDER / INHALATION RLD, RS 2020-10-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N202049-001 BRONCHITOL 40MG POWDER / INHALATION RLD, RS 2020-10-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N202049-001 BRONCHITOL 40MG POWDER / INHALATION RLD, RS 2020-10-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N202049-001 BRONCHITOL 40MG POWDER / INHALATION RLD, RS 2020-10-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N202049-001 BRONCHITOL 40MG POWDER / INHALATION RLD, RS 2020-10-30 8869cabd3fbd…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N202049-001 BRONCHITOL 40MG POWDER / INHALATION RLD, RS 2020-10-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N202049-001 BRONCHITOL 40MG POWDER / INHALATION RLD, RS 2020-10-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N202049-001 BRONCHITOL 40MG POWDER / INHALATION RLD, RS 2020-10-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N202049-001 BRONCHITOL 40MG POWDER / INHALATION RLD, RS 2020-10-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N202049-001 BRONCHITOL 40MG POWDER / INHALATION RLD, RS 2020-10-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N202049-001 BRONCHITOL 40MG POWDER / INHALATION RLD, RS 2020-10-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N202049-001 BRONCHITOL 40MG POWDER / INHALATION RLD, RS 2020-10-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N202049-001 BRONCHITOL 40MG POWDER / INHALATION RLD, RS 2020-10-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N202049-001 BRONCHITOL 40MG POWDER / INHALATION RLD, RS 2020-10-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N202049-001 BRONCHITOL 40MG POWDER / INHALATION RLD, RS 2020-10-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N202049-001 BRONCHITOL 40MG POWDER / INHALATION RLD, RS 2020-10-30 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N202049-001 BRONCHITOL 40MG POWDER / INHALATION RLD, RS 2020-10-30 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N202049-001 BRONCHITOL 40MG POWDER / INHALATION RLD, RS 2020-10-30 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N202049-001 BRONCHITOL 40MG POWDER / INHALATION RLD, RS 2020-10-30 a50c72e98297…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 53 observed states.
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 10122-212 BRONCHITOL (MANNITOL) CAPSULE [CHIESI USA, INC.] 5 Legacy NDC 20240123_454f092e-dcd0-47bd-a521-b07400403dad.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 10122-212-02 10122021202 1 BLISTER PACK in 1 CARTON (10122-212-02) > 10 CAPSULE in 1 BLISTER PACK (10122-212-01) 1 blister pack 2021-02-01 0000-00-00 Yes No Current 10122-212-04 10122021204 1 BLISTER PACK in 1 CARTON (10122-212-04) > 10 CAPSULE in 1 BLISTER PACK (10122-212-01) 1 blister pack 2021-02-01 0000-00-00 No No Current 10122-212-14 10122021214 14 BLISTER PACK in 1 CARTON (10122-212-14) > 10 CAPSULE in 1 BLISTER PACK (10122-212-01) 14 blister pack 2021-02-01 0000-00-00 No No Current 10122-212-56 10122021256 4 CARTON in 1 BOX (10122-212-56) > 14 BLISTER PACK in 1 CARTON (10122-212-14) > 10 CAPSULE in 1 BLISTER PACK (10122-212-01) 4 carton 2021-02-01 0000-00-00 No No Current